505(b)(2) NDA Pathway
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505(b)(2) NDA Pathway

Accelerating Innovation through Existing Data

Overview

The 505(b)(2) pathway allows you to leverage existing public data to accelerate approval and reduce costs. We are experts in this nuanced pathway, helping you identify the right 'bridge' to the listed drug and constructing a scientific argument that minimizes your own clinical burden.

Key Features

Reference Listed Drug (RLD) selection
Bridging study strategy
Patent certification (Paragraph IV)
Labeling carve-outs

Our Process

1

Feasibility

Determining if your product qualifies and identifying the RLD.

2

Gap Analysis

Identifying what new data is needed vs. what can be bridged.

3

Submission

Crafting the unique 505(b)(2) argument in your NDA.

Project Complete & Deliverables Provided

Frequently Asked Questions

A 505(b)(2) NDA is a hybrid application that relies partly on your own data and partly on the FDA's previous findings for an approved 'listed drug' or published literature. It's defined in Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. This pathway is ideal for modifications to existing drugs—new formulations, new routes, new combinations, or new indications.

Why Choose Us

  • Reduced clinical trial costs
  • Faster time to market
  • Lower development risk
  • Market exclusivity opportunities

Get More Details

Request a personalized consultation and detailed information about this service.

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Detailed service information
Custom timeline & proposal
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What Our Clients Say

"We thought we'd need full clinical trials for our extended-release formulation. Adelphi identified a 505(b)(2) pathway that required only a PK bridging study. We saved three years and $30 million in development costs."

Dr. Michelle Torres

Chief Scientific Officer

Specialty Pharma

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